Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Applicants’ amendments and arguments filed 02/27/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 7, 11, 14-15, 19-20, and 23-28 are canceled.
Claims 1 and 16-17 are amended.
Claims 9-10, 12-13, 16-18, 21-22, are 29-32 remain withdrawn.
Claims 1-6 and 8 are examined on the merits.
Claim Interpretation
Claim 1 utilizes the relative term "about". The term “about” is defined by the instant specification as +/-5%, therefore, the term “about” in claim 1 will be interpreted by the examiner to mean +/- 5% the claimed value.
Claim 5 recites the limitation of “substantially free” which is defined in Applicant’s specification to be “a composition that comprises less than about 1 wt%, less than about 0.5 wt%, less than about 0.25 wt%, less than about 0.1 wt%, less than about 0.05 wt%, less than about 0.01 wt%, or 0 wt% of the component” ([0034]). Examiner broadly interprets this limitation to be 1.1% (broadly interpreting about to mean =/-10%) or less.
New Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the shell composition comprising a marking formulation including a marking component… wherein the shell composition comprised a marking formed by applying laser… and wherein the marking corresponds…” which is unclear if the “marking” is the same as the “marking component”, or if they are in combination with each other, or independent of each other.
For the purpose of moving prosecution forward, the examiner broadly interprets them as being independent of each other.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Momoi (US20090304601A1, published 12/10/2009, hereafter Momoi).
Momoi claims a method of marking a composition for use in oral administration (title and claim 1; according to the claim limitations of the instant claim 1). Momoi claims dispersing a change in color inducing oxide in the composition (claim 1; according to the claim limitations of the instant claim 1). Momoi teaches the laser beam is at a wavelength of from 200nm to 1100nm (abstract and claim 12; according to the claim limitations of the instant claim 1). Momoi teaches the change in color inducting oxide is at least one that is selected from the group consisting of titanium dioxide, yellow ferric oxide, and red ferric oxide (abstract and claim 5; according to the claim limitations of the instant claims 1, 2, and 4). Momoi further teaches black-iron-oxide coating (table 2, comparative example 7; according to the claim limitation of the instant claim 4). Momoi teaches the capsules are made by filling a capsule coating layer which contains at least one type of metal oxide selected from the group consisting of titanium dioxide, yellow ferric oxide, and red ferric oxide ([0042]; according to the claim limitations of the instant claims 1, 2, and 4). Momoi teaches a soft capsule having a gelatin coating layer that contains glycerin ([0051]; according to the claim limitations of the instant claims 1 and 3). The same paragraph of Momoi teaches the capsule has a white color that after irradiation demonstrated a letter marking in a highly visible gray ([0051]; according to the claim limitations of the instant claim 1). Momoi teaches the composition have other additives to include plasticizers such as glycerin ([0044]; according to the claim limitations of the instant claim 3). Momoi claims the amount of titanium dioxide is from 0.01 to 20 parts by weight based on 100 parts of the coating layer (claim 10; according to the claim limitations of the instant claim 5). Lastly, Momoi teaches the laser used is a Deep UV laser ([0053], table 3; according to the claim limitations of the instant claim 8).
Momoi does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Momoi with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Claim 6 are rejected under 35 U.S.C. 103 as being unpatentable over Momoi (US20090304601A1, published 12/10/2009, hereafter Momoi) in view of EFSA (European Food Safety Authority (EFSA). (2021, May 6). Titanium dioxide: E171 no longer considered safe when used as a food additive. European Food Safety Authority. https://www.efsa.europa.eu/en/news/titanium-dioxide-e171-no-longer-considered-safe-when-used-food-additive, hereafter EFSA).
Although Momoi teaches a soft capsule composition comprising a fill material and a coating composition comprising iron oxide and the option of ferric (iron) oxide or titanium oxide, it does not explicitly teach an embodiment without titanium oxide.
EFSA teaches that titanium dioxide is no longer considered safe when used as a food additive (title). EFSA teaches that titanium dioxide is used as a food colour and is used in medicines (page 4, 1. What is titanium dioxide). EFSA teaches a concern for genotoxicity caused by titanium dioxide (page 5, 3. What is EFSA saying…).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to selectively modify the soft gelatin capsule coating composition comprising iron oxide that has a fill material as outlined by Momoi by the selective omission of titanium dioxide as outlined by EFSA under TSM, see MPEP 2143(G). As outlined by EFSA, titanium dioxide is considered unsafe and a concern for genotoxicity which would motivate someone skilled in the art to advantageously select iron oxide without titanium dioxide in the composition of Momoi as it would have a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, and 5-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-7 of copending Application No. 18/516295 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
18/516295 claims a softgel capsule comprising a fill material and a shell composition, wherein the shell composition comprises a marking formulation including a marking component (claim 1; according to the claim limitations of the instant claim 1). Claim 1 of 18/516295 further claims laser irradiation is applied to the softgel capsule (according to the claim limitations of the instant claim 1). Claim 2 of 18/516295 claims the marking component comprises a metal oxide (according to the claim limitation of the instant claim 1). Claim 3 of 18/516295 claims the marking formulation further comprises a plasticizer and a gelatin (according to the claim limitations of the instant claim 3). Claim 4 of 18/516295 claims the metal oxide is iron oxide (according to the claim limitations of the instant claim 1). Claim 6 of 18/516295 claims the marking formulation is substantially free of titanium dioxide and claim 7 of 18/516295 claims the marking formulation does not include titanium dioxide (according to the claim limitations of the instant claims 5-6).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13-14 of copending Application No. 17/629,126 (reference application) in view of Momoi (US20090304601A1, published 12/10/2009, hereafter Momoi). Although the claims at issue are not identical, they are not patentably distinct from each other.
17/629,126 claims a softshell capsule formulation comprising (a) a softshell composition comprising a natural gelling agent and a plasticizer; and (b) a fill composition (claim 1; according to the claim limitations of the instant claims 1 and 3). 17/629,126 claims the shell composition further comprises a colorant, wherein the colorant comprises at least one of iron oxide, iron hydroxide, titanium dioxide, or combinations thereof (claim 13; according to the claim limitations of the instant claims 1 and 2). 17/629,126 claims the softshell formulation further comprises an opacifier, titanium oxide (claim 14; according to the claim limitations of the instant claim 2).
17/629,126 fails to teach the capsule has a laser marking at a wavelength of about 100nm to about 400 nm and the marking has a different color than the capsule as in instant claim 1.
As outlined above, Momoi teaches a soft gelatin capsule composition with a UV laser, with a wavelength of 200nm to 1100nm, marking on a coating composition in which the marking is a different color than the coating and the coating has a fill material.
One skilled in the art before the effective filing date of the claimed invention would claim a softshell capsule with a gelling agent and plasticizer, an iron oxide colorant, and a fill composition as outlined by 17/629,126 with the ready for improvement with the known technique of marking the capsule with a UV laser at a wavelength of 200nm to 1100nm in which the marking is a different color then the capsule as outlined by Momoi. Adding the forementioned components to a softshell capsule as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant’s arguments filed on 02/27/2026 are considered by the examiner.
In regards to the previous 35 USC § 102 and 35 USC § 103 rejections, Applicant’s amendments have necessitated new grounds of rejection.
In regards to Applicant’s argument against the Double Patenting rejections, Applicant requests the rejections be held in abeyance until claims are otherwise allowable.
A request to hold abeyance is an improper response to a double patenting rejection. Since Applicants fail to properly respond to the rejections of record, the double patenting rejections over are maintained and updated to account for amendments.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611
Prosecution Insights